2014/LSIF/PD/015 Centralization and Regionalization - Round Table Discussion

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1 2014/LSIF/PD/015 Centralization and Regionalization - Round Table Discussion Submitted by: LuxConsulTrans Policy Dialogue and Workshop on Attaining a Safe and Sustainable Blood Supply Chain Manila, Philippines 30 September 1 October 2014

2 APEC Forum on Blood Supply Chain, Manila Day One : 16:45-18:00 Centralization and regionalization Round Table discussion with 6 panelists Moderator: Dr Jean-Claude FABER, Luxembourg jean.claude.faber@numericable.lu immediate past-president of IHN (International Haemovigilance Network) member of WHO Expert Panel on Blood Transfusion APEC Forum on Blood Supply Chain Jean-Claude FABER Centralisation: 1 Introduction

3 APEC Forum on Blood Supply Chain Centralization (resp. regionalization) Round Table discussion with panelists: Dr. Ina-Noelia Pérez-Huaynalaya, Peru and ISBT Dr. Yuyun SM Soedarmono, Red Cross, Indonesia Ms. Tasanne Sakuldamrongpanich, Red Cross, Thailand Dr. Maria Victoria Abesamis, Dept. of Health, Philippines Dr. Pham Tuan Duong, Ministry of Health/NIHBT, Viet Nam Dra. Omar Sanchez Ramirez, Normalizacion MoH, Mexico APEC Forum on Blood Supply Chain Jean-Claude FABER Centralisation: 2 Introduction

4 Definition of Centralisation (or centralization) In general, is meant the process by which the activities of an organisation, particularly those regarding planning and decision-making, become concentrated within a particular location/ group or keeping all of the important decisionmaking powers within head office or the centre of the organisation. In political science, centralisation refers to the concentration of a government s power both geographically and politically into a centralized government. In business, centralisation and decentralization refer to where decisions are made in the chain of command. APEC Forum on Blood Supply Chain Jean-Claude FABER Centralisation: 3 Introduction

5 NBS

6 APEC Forum on Blood Supply Chain Centralization (resp. regionalization): Introduction by the moderator Understand the difference between NBS (National Blood System) vs. NBTS (National Blood Transfusion Service) What is?: A. a (fully) centralized NBTS B. a centrally coordinated NBTS C. a lose network of producing blood centres C. a fragmented system/ situation. APEC Forum on Blood Supply Chain Jean-Claude FABER Centralisation: 5 Introduction

7 National Blood System (NBS) NBS is the system (or scheme) in a country allowing for blood transfusions and including the responsible authority, the producers and the users as well as associated structures. NBS offers the frame and contains the vital elements/ constituents of the system in a robust way and allows them to function in a balanced and coordinated way to achieve the ultimate goal of safe blood donations and blood transfusions available and accessible to all who are in a need.

8 Legislator Orchestrator Govt MOH NBA Laws Regulations Policies Funding Strategy National Blood Plan National Blood System (NBS) Products Services NBTS HQ/NO NBTC RBTCs CCDs Producer BRU Regulator Oversight: I&A,HV Licence User Prov..1 Prov..2 Prov..3 Prov..n Treatment Hospitals Prov..1 Prov..2 District.3 District..n

9 Producer(s) in the NBS NBTS (National Blood Transfusion Service)=a countrywide organisation with responsibility for the production/ provision/ supply of blood and blood products for transfusion and for the liaison with clinical services on appropriate use of blood for patient care. It comprises a NBTC, RBTCs, other BTCs. It coordinates all activities from blood donor recruitment and selection, collection, testing, processing/production, storage and distribution of blood and blood products (BC-blood components and PD -plasma derivatives), QA, NBTC (National Blood Transfusion Centre)=the leading institute of the NBTS, a reference centre or centre of excellence for the country RBTC/PBTC (Regional/Provincial Blood Transfusion Centre)= blood centre/establishment with all activities from collection to distribution to hospitals in a defined region/ province blood bank in the hospital (pre-tx)

10 Trends in European Blood Transfusion (Dr J. Leikola, Finland 2001) 1. Regulation becomes stricter 2. Perceived and real blood safety overriding everything 3. Trends towards centralisation Reasons for consolidation: Good Manufacturing Practice (GMP),Quality Assurance (QA) NAT (PCR) testing possible only in selected laboratories Implementation of national blood policy Better control by health authorities Economies of scale

11 Situation in Blood Transfusion worldwide in 2012 Universal trend towards National Services leading to centralisation and coordination: Europe: UK, France, Finland, Ireland, Belgium, Netherlands, Switzerland,... even Italy and other federalistic countries) North America (Canada, US to some degree: clusters ARC, ABC, Blood Systems,...) Pacific: Australia, New Zealand Asia: Japan, Malaysia, Indonesia, Thailand, Vietnam, Laos,... but some countries are lacking behind;(singapore, Hongkong, Macau) Africa: a lot to do (except: South Africa, some Mediterranean countries,...) Latin America: mostly fragmented, except Nicaragua, Colombia The key to our success is a simultaneous centralisation and decentralisation H. R. Nevanlinna 1968, Finland Centralisation is not an all-or-nothing function J. Leikola, 2001, Finland

12 APEC Forum on Blood Supply Chain Advancing centralization (resp. regionalization) What are the respective advantages/ disadvantages of: A. centralized model B. centrally coordinated C. loose network of autonomous blood centres D. fragmented N.B. National, regional, local, institutional Supra-national (a geographic region/ area, economic alliance, Global What have been obstacles/ difficulties/ problems in centralization/ consolidation?

13 APEC Forum on Blood Supply Chain Advancing centralization (resp. regionalization) What is the single most important problem for developing APEC countries and the most significant danger for their populations in this context?

14 APEC Forum on Blood Supply Chain Centralization (resp. regionalization) Round Table discussion with panelists: Dr. Ina-Noelia Pérez-Huaynalaya, Peru and ISBT Dr. Yuyun SM Soedarmono, Red Cross, Indonesia Ms. Tasanne Sakuldamrongpanich, Red Cross, Thailand Dr. Maria Victoria Abesamis, Dept. of Health, Philippines Dr. Pham Tuan Duong, Ministry of Health/NIHBT, Viet Nam Dra. Omar Sanchez Ramirez, Normalizacion MoH, Mexico APEC Forum on Blood Supply Chain Jean-Claude FABER Centralisation: 13 Introduction

15 APEC Forum on Blood Supply Chain Advantages of centralization (resp. regionalization) Advantages of centralized organization: - Economies of scale; national budgeting possible - Harmonization of product range - Standardization of quality & safety of blood and blood products - Effectiveness and efficiency of operations increased - Inventory management improved (outdating reduced) - Logistics facilitated (blood bags, TTIs, ) - Screening (EIA, CLEIA, ) in fewer laboratories - NAT testing at a reasonable cost in a few testing sites - Regular inspections by regulatory authority in the BCs possible - Haemovigilance strengthened (for donors, recipients, products, processes, personnel) - Rapid alert & early warning speeded up - CAPA uniform and implementation time shortened,

16 APEC Forum on Blood Supply Chain Advantages of centralization (resp. regionalization) Other advantages of centralized organisation: Uniformisation facilitated (for methods&techniques, for equipment, material&reagents, products&services) Maintenance and repair of equipment facilitated Human resources optimized (especially in countries with lack of qualified, experienced personnel) Plasma programme feasible (for PDMP through contract fractionation) Competition for donors and customers (hospitals) avoided etc APEC Forum on Blood Supply Chain Jean-Claude FABER Centralisation: 15 Introduction

17 Low volume donations: here 250 ml a major obstacle for adequate blood supply to satisfy demand

18 APEC Forum on Blood Supply Chain Advancing centralization (resp. regionalization) Potential risks and drawbacks of centralized organisation: APEC Forum on Blood Supply Chain Jean-Claude FABER Centralisation: 17 Introduction

19 APEC Forum on Blood Supply Chain Advancing centralization (resp. regionalization) Other potential risks and drawbacks of centralized organisation: Longer reaction time in emergencies Delays in blood supply/ delivery in difficult conditions (geographic, topographic, meteorologic, disasters, ) Loss of flexibility Distance to patients in hospitals etc APEC Forum on Blood Supply Chain Jean-Claude FABER Centralisation: 18 Introduction

20 What have been obstacles/ difficulties/ problems in centralization/ consolidation? Politics Compartimentation culture Local/ individual interests Resistance to change etc APEC Forum on Blood Supply Chain Jean-Claude FABER Centralisation: 19 Introduction

21 APEC Forum on Blood Supply Chain Advancing centralization (resp. regionalization) What to centralize (absolutely): Plasma (for fractionation, for exchange with finished products PDMP, for selling, ) Purchasing of material (equipment, disposables, reagents, ) Training programmes Standards and guidelines (S&G) Quality management (QM) concept APEC Forum on Blood Supply Chain Jean-Claude FABER Centralisation: 20 Introduction

22 APEC Forum on Blood Supply Chain Advancing centralization (resp. regionalization) What can be decentralized (although coordination needed): APEC Forum on Blood Supply Chain Jean-Claude FABER Centralisation: 21 Introduction

23 Experience Regionalization and Centralization Conclusions: APEC Forum on Blood Supply Chain Jean-Claude FABER Centralisation: 22 Introduction